Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-04-11 @ 10:18 PM
Study NCT ID:
NCT05655793
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "The type of biospecimen that is retained is tear fluid collected with Schirmer's strips, CSF and blood."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capability of tear biomarkers to discriminate individuals with neurodegeneration from those without neurodegeneration and assess the change in biomarker levels over time.', 'timeFrame': 'Sampling done at t= 0, 1 and 2 years.', 'description': "Levels of tear biomarkers will be determined from the Schirmer's strips. The biomarker levels will be analysed to see whether they can be discriminate between people with and without neurodegeneration."}], 'secondaryOutcomes': [{'measure': 'The difference in tear biomarker level between patients and controls, and between patient groups and how these differences change over time.', 'timeFrame': 'Sampling done at t= 0, 1 and 2 years.', 'description': 'Additional analysis to see whether tear biomarkers can also discriminate patients from controls and differences inbetween patient groups.'}, {'measure': 'Correlation of biomarker levels in tears, blood and cerebral spinal fluid (CSF).', 'timeFrame': 'Baseline measurements (t=0) will be used to determine correlation.', 'description': 'This analysis will be done to determine the correlation between biomarkers of different body fluids.'}, {'measure': 'Correlation between tear biomarkers and other ocular imaging biomarkers, as well as assessing the change of this correlation over time.', 'timeFrame': 'Imaging done at t= 0, 1 and 2 years.', 'description': 'The correlation between tear biomarkers and ocular imaging biomarkers (e.g. thickness of the retinal nerve fiber layer, retinal vasculature tortuosity) will be analysed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tear Fluid', 'Retinal imaging', 'Biomarkers'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '37543602', 'type': 'DERIVED', 'citation': "van de Sande N, Ramakers IHGB, Visser PJ, Verhey FRJ, Verbraak FD, Bouwman FH, Berendschot TTJM, Nuijts RMMA, Webers CAB, Gijs M. Tear biomarkers for Alzheimer's disease screening and diagnosis (the TearAD study): design and rationale of an observational longitudinal multicenter study. BMC Neurol. 2023 Aug 5;23(1):293. doi: 10.1186/s12883-023-03335-y."}]}, 'descriptionModule': {'briefSummary': "The goal of this observational longitudinal study is to investigates whether tear fluid is a non-invasive source of biomarkers for Alzheimer's disease. The main aim of the study is to evaluate diagnostic accuracy measures (sensitivity and specificity) of tear and retinal biomarkers to discriminate individuals with and without neurodegeneration.\n\nTear fluid from participants will be collected non-invasively with Schirmer's strips, which is a small paper strip placed in the lower eye lid for a maximum of 5 minutes. Additionally, standard, ultra-wide field and cross-sectional retinal images will be obtained."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients will be selected from the population that visit the memory clinic and are willing to participate in scientific research.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (healthy controls):\n\n* Available CSF, PET, CT or MRI data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study)\n* Absence of cognitive complaints or treatment and did not seek help for cognitive complaints in the past\n* MMSE score 26-30 at baseline\n* Age \\> 50 years\n* Available for follow-up (up to 24 months)\n* Written informed consent obtained and documented\n\nInclusion criteria (patients):\n\n* Available CSF, PET, CT or MRI data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study)\n* Available for follow-up (up to 24 months)\n* Written informed consent obtained and documented\n* Capable of giving informed consent themselves (MMSE score \\> 17/30)\n\nExclusion Criteria (all subjects):\n\n* Ocular conditions that could influence tear biochemical parameters (including eye infection, eye inflammation, eye surgery within the last 28 days or other acute eye conditions)\n* Neurological or systemic chronic conditions known to interfere with retinal thickness (e.g., glaucoma, diabetes mellitus)\n* Ocular conditions interfering with optical coherence tomography (OCT) quality/retinal thickness: e.g. severe cataract, age-related macular degeneration, and glaucoma'}, 'identificationModule': {'nctId': 'NCT05655793', 'acronym': 'TearAD', 'briefTitle': "The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis", 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': "The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis", 'orgStudyIdInfo': {'id': '20-033'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With Neurodegeneration', 'description': 'Includes patients with mild cognitive impairment and dementia', 'interventionNames': ["Diagnostic Test: Tear Fluid collection (Schirmer's strip)", 'Diagnostic Test: Retinal imaging']}, {'label': 'Without Neurodegeneration', 'description': 'Includes healthy controls and patients with subjective cognitive decline', 'interventionNames': ["Diagnostic Test: Tear Fluid collection (Schirmer's strip)", 'Diagnostic Test: Retinal imaging']}], 'interventions': [{'name': "Tear Fluid collection (Schirmer's strip)", 'type': 'DIAGNOSTIC_TEST', 'description': "Tear fluid will be collected non-invasively form all participants with the use of Schirmer's strips, which is a small paper strip placed in the lower eye lid for a maximum of 5 minutes.", 'armGroupLabels': ['With Neurodegeneration', 'Without Neurodegeneration']}, {'name': 'Retinal imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'The retina from all participants will be visualised with the use of a standard (Clarus 700 Zeiss), ultra-wide field (Optos), and cross-sectional (Optical Coherence Tomography) retinal images.', 'armGroupLabels': ['With Neurodegeneration', 'Without Neurodegeneration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marlies Gijs, PhD', 'role': 'CONTACT', 'email': 'marlies.gijs@mumc.nl'}], 'facility': 'Academic Hospital Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Frank Verbraak, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Amsterdam University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Marlies Gijs, PhD', 'role': 'CONTACT', 'email': 'marlies.gijs@mumc.nl', 'phone': '+31 (0)43 3872241'}, {'name': 'Nienke van de Sande, MSc', 'role': 'CONTACT', 'email': 'nienke.van.de.sande@mumc.nl', 'phone': '+31 (0)43 3875345'}], 'overallOfficials': [{'name': 'Marlies Gijs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}